US5106368A - Collapsible lumen catheter for extracorporeal treatment - Google Patents

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Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M2025/0025—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter having a collapsible lumen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
  • A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
  • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
  • A61M25/0071—Multiple separate lumens

Definitions

• the present invention relates generally to extracorporeal treatments such as hemodialysis in which blood and its components are treated outside of the body and require access to the vascular system of the human body and, in particular, to multi-lumen catheters for use in such treatments.
• a more serious problem with the plain tube catheter is that once it has been removed, it can not easily be reinserted into the same site. Therefore, jugular vein sites are soon used up and no longer available to the patient.
• One physician has used a peel-away sheath for percutaneous insertion of this catheter, but a very large 18 French sheath was required to accommodate the largest cross-sectional dimension of the catheter. Most physicians would judge the size of an 18 French introducer sheath to be undesirable.
• a catheter having two large diameter lumens for high blood flow rates and also having an external cross-sectional dimension which is not too large for vascular access includes a simple double-D lumen configuration.
• the walls of the catheter are thin, and the equal area lumens make full use of the available space.
• the catheter is made of relatively stiff material which is unsuitable for long-term placement. If this temporary catheter is made of a silastic material, the intake lumen collapses under the influence of the strong negative intake pressure. Furthermore, the septum between the two lumens is pulled into the negative pressure lumen, thereby adversely changing the cross-sectional area in the two lumens as well as the blood flow rates therethrough.
• Temporary or short-term catheters of the double-D configuration are used in large numbers all over the world, but they have a disconcerting tendency to get blocked. These catheters are made of a relatively stiff material to prevent the lumens from collapsing. A problem with the stiff material is that the catheter kinks or buckles when bent more than 180°. This also leads to lumen obstruction and the potential risk of cracking or splitting the wall. Furthermore, catheter stiffness combined with a tapered end for insertion over a guide wire has been responsible for many penetrating injuries of the wall of the superior vena cava or right atrium. There have been many deaths caused by such spontaneous perforations. This can occur by erosion, days or weeks after the catheter is originally inserted. However, no penetrating vein wall injuries have been reported with the use of blunt-end silastic catheters.
• Silastic catheters with the double-barreled shot-gun configuration are remarkably resistant to kinking even when bent sharply through 180°. Also a cylindrical lumen is the theoretical optimum to achieve maximum flow for the smallest surface area of the wall. Finally, the cylindrical lumen avoids the sharp corners in the wall of the double-D configuration where, at least theoretically, clotting is more likely to occur.
• the side-by-side open-ended design of the long-term catheter has much less tendency to block, but has not been used as a temporary catheter since it cannot easily be introduced percutaneously.
• the circular intake lumen of the long-term catheter is similarly recessed back from the distal end of the return lumen to minimize blood recirculation.
• a problem with this is that the wall of the extended positive pressure return lumen provides a surface for clots to adhere.
• the walls of the negative pressure intake lumen are provided with side ports. However, it is believed that these side ports may actually encourage clotting.
• the long term catheter typically employs a fixed-position dacron cuff which may not be conveniently positioned to stabilize the catheter. Removal of the catheter and release of the dacron cuff requires a new incision and dissection of the cuff by a surgeon. Dissecting the cuff from ingrown tissue invariably leads to bleeding, which may be hard to control.
• This extracorporeal treatment catheter has a collapsible lumen for percutaneous insertion into a blood vessel through a much smaller diameter peel-away introducer sheath.
• This extracorporeal treatment catheter comprises first and second elongated tubular members having respective first and second longitudinal passageways therein, commonly referred to as lumens.
• the first and second tubular members are laterally attached and have respective first and second walls with different thicknesses about the two lumens.
• the second lumen wall is thinner than the first lumen wall and is collapsible about the second tubular member for inserting them both into a blood vessel through a smaller diameter introducer sheath.
• the collapsed lumen When inserted in a vein, the collapsed lumen returns to its original shape.
• the thickness of the first lumen wall is twice as thick as that of the second lumen wall. This advantageously permits percutaneous insertion of the catheter with a stiffening cannula over a wire guide and through the much smaller diameter introducer sheath.
• the distal end of the two tubular members includes a slippery-when-wet coating for further easing the percutaneous insertion of the catheter through the introducer sheath.
• the intake lumen wall thickness is thick enough to withstand the negative pressure associated with hemodialysis treatment machines without the intake lumen collapsing.
• the return lumen wall is thinner than the intake lumen wall to allow it to collapse about the first member for percutaneous insertion through the smaller diameter introducer sheath, but yet thick enough to withstand the positive pressure of the returning blood without stretching.
• the thickness of the intake lumen wall to that of the return lumen wall may vary in a range of one and a half to three times as thick and still provide satisfactory blood flow characteristics.
• the cross-sectional shape of the two lumens are substantially equal in area to maintain balanced intake and return blood flows. Furthermore, the cross-sectional shape of the two lumens is generally circular to advantageously maintain maximum laminar blood flow for a given wall surface area.
• the negative pressure intake lumen is longer than the positive pressure return lumen at the distal ends, which is opposite to that of presently available hemodialysis catheters.
• the shorter positive pressure return lumen advantageously reduces the accumulation of blood clots and resulting blockage with only a minimal increase in blood recirculation between the two lumens.
• the catheter has been segregated into distal and proximal segments.
• the distal segment advantageously includes different thickness walls for collapsing the thin-walled positive pressure return lumen about the negative pressure intake lumen and inserting the collapsed distal segment through a smaller diameter introducer sheath.
• the proximal segment has a cross-sectional shape of a generally elliptical character to form a leak proof fit when inserted into the vein wall.
• both of the segments are formed from a biocompatible material such as silastic for long-term use and have a predetermined durometer for pushing the catheter through the introducer sheath and blood vessel.
• the catheter also advantageously includes a moveable collar or grommet which can be adjusted in position on the proximal segment and has a flange extending therefrom to secure the catheter to the surrounding tissues.
• the grommet can be released by simply pulling on it or by dissecting it out. In either case, there is no bleeding.
• FIG. 1 depicts a dual lumen hemodialysis catheter having a collapsible lumen for percutaneous insertion through a peel-away introducer sheath of the present invention
• FIG. 2 depicts a cross-sectional view of the distal segment of the catheter of FIG. 1 along the line 2--2;
• FIG. 3 depicts a cross-sectional view of the distal segment of the catheter of FIG. 1 in a collapsed state and positioned in an introducer sheath;
• FIG. 4 depicts a cross-sectional view of the proximal segment of the catheter of FIG. 1 along the line 4--4.
• FIG. 1 Depicted in FIG. 1 is a dual lumen catheter 100 for use in an extracorporeal treatment such as hemodialysis and the like.
• This vascular access catheter is percutaneously inserted in a blood vessel, such as preferably the jugular or femoral vein, for either short-term or long-term hemodialysis treatment of the patient.
• the jugular access site is preferable to the subclavian vein because it is much less likely to cause subclavian vein thrombosis.
• Subclavian vein thrombosis is a serious long-term disability for a patient on dialysis if it is not diagnosed and successfully treated at an early stage, because it interferes with A-V fistula construction in the ipsilateral arm, leading to a permanently swollen congested arm as long as the fistula is functioning.
• Internal jugular vein thrombosis is probably not common after internal jugular cannulation, but it causes no disability even if it occurs and is not treated, except that the patient loses a potential access site.
• the catheter basically comprises a dual lumen main body 101 attached to a single lumen, arterial clamping limb 104 and a single lumen, venous clamping limb 105 via interconnecting manifold 106.
• two female Luer lock connectors 107 and 108 are connected in a well-known manner to arterial and venous clamping limbs 104 and 105, respectively.
• the main body of the catheter includes a distal segment 102 and a proximal segment 103 extending proximally therefrom and is comprised of a flexible biocompatible material such as 70 durometer silicon or silastic.
• Distal segment 102 includes a thick-walled, negative pressure, elongated tubular member 201 and a shorter, thin-walled, collapsible, positive pressure, elongated tubular member 202 attached laterally thereto.
• the catheter further includes lockable clamps 117 and 118 for clamping arterial and venous clamping limbs 104 and 105, respectively.
• One such clamp is the BETA-CAP clamp available from Quinton Instrument Co., Seattle, Washington. Slide clamps from the Qosina Co. are also acceptable.
• Catheter 100 also includes an anchoring grommet 116 having a ring-like collar 111 positioned around and slidably moveable along proximal segment 103.
• Flange 112 and 113 extend laterally from the collar and have respective apertures 114 and 115 formed therein to insert sutures therethrough.
• the grommet is positioned on the proximal segment where it crosses the supraclavicular fossa. Sutures placed through the apertures secure the catheter to the surrounding tissue.
• the shape of the grommet permits capture of the catheter without compressing it.
• the smooth rounded flanges allow the grommet to be pulled out with the catheter when it is removed.
• the anchoring sutures will tear out of the flanges and the only thing left inside the patient will be the sutures themselves.
• the overall length of the main body of the catheter from the manifold to the distal tip thereof depends on the insertion site selected by the physician.
• the main body of the catheter from manifold to tip is preferably 26 cm in length with an 11 cm distal segment.
• the main body of the catheter is approximately 30 cm in length with the distal segment being 15 cm.
• the distal segment 102 includes a collapsible tubular member 202 for inserting the distal segment with stiffening cannula 109 inserted in tubular member 201 over wire guide 110 through a well-known smaller diameter peel-away introducer sheath (not shown).
• the introducer sheath which should be no more than 10 cm in length. This will allow the distal segment to be inserted into the sheath with the distal tip protruding slightly beyond the distal end of the sheath before it is peeled away.
• Distal segment 102 includes thick-walled elongated tubular member 201 and thin-walled elongated tubular member 202 attached laterally to member 202 and collapsible thereon.
• the thick-walled tubular member includes first wall 203 surrounding first longitudinal passageway 204 included therein.
• This first longitudinal passageway is designated a negative pressure intake lumen for receiving blood from the vessel of a patient for hemodialysis treatment.
• the thickness of first wall 203 is approximately 0.020" with the cross-sectional diameter of passageway 204 being approximately 0.080".
• the distal end of the negative pressure intake lumen may be outwardly tapered to prevent clotting and the collection of blood clots thereon.
• the dimensions of tubular member 201 and negative pressure lumen 204 allow for blood flow rates of 350-400 ml per minute without collapsing.
• the second, thin-walled collapsible tubular member 202 includes a second longitudinal passageway 205 with second wall 206 positioned thereabout.
• the thickness of second wall 206 is approximately 0.010" with longitudinal passageway having a cross-sectional diameter of approximately 0.080", which is equivalent to that of passageway 204.
• the maximum cross-sectional dimension of distal segment is approximately 0.210" plus allowances for fabrication and slip coating 207, which will pass through an 18 French (0.236") aperture.
• Second longitudinal passageway 205 is designated the positive pressure return lumen for returning blood from a hemodialysis machine to the vessel of the patient.
• the cross-sectional area of passageways 204 and 205 are substantially equivalent to provide approximately equal flow rates to and from the patient.
• the distal segment also includes slip coating 207 which acts as a lubricant to insert the distal segment through the introducer sheath.
• slip coating 207 acts as a lubricant to insert the distal segment through the introducer sheath.
• One such slip coating is a slippery-when-wet hydrophilic coating that is commercially available from Hydromer Inco., Whitehouse, N.J.
• the slip coating is applied to the outside surface of distal segment 102. This hydrophilic slip coating is wetted during the insertion procedure to provide a slippery surface for easier insertion through the peel-away introducer sheath.
• the presence of blood or other fluids in the introducer sheath further lubricates the collapsed distal segment as it is being inserted therethrough.
• a 30 cm thin-walled, positive pressure member of a 70 durometer silicon material catheter was able to tolerate a blood flow of 500 ml per minute and a negative pressure of 300 mm/Hg without collapsing when flows were reversed, and it was used as a negative pressure lumen.
• the ability to reverse the flows is important if on occasion the thick-walled lumen fails to provide adequate out flow.
• the dialysis treatment community has been demanding these flow rates, but until now has not been provided with catheters to provide these flow rates.
• blood flow rates of 400 ml per minute are attainable with arterial and venous pressure barely exceeding 200 mm of mercury.
• the cross-sectional shape of the passageways are also preferably circular to maintain laminar fluid flow.
• the introduction of a smaller radius into the cross-sectional shape of the passageway typically provides opportunities for the blood flow to become turbulent and increases the risk of clotting.
• the tubular members must be thin and flexible enough for insertion into the vascular system without kinking or collapsing in operation.
• Negative pressure lumen wall 203 must be thick enough to withstand the negative pressures inwardly exerted thereon by modern hemodialysis treatment machines without collapsing during intake of blood from the patient.
• Thinner, positive pressure lumen wall 206 must be thick enough to withstand the positive pressures outwardly exerted thereon without stretching.
• the diameter of the passageways should be as large as possible to provide adequate flow rates as demanded by the hemodialysis treatment community.
• the maximum cross-sectional dimension of the catheter must be minimal for percutaneous insertion into the blood vessel such as through a 12 French (0.158" ) peel-away introducer sheath.
• the thickness of negative pressure lumen wall 203 is preferably twice as thick as that of positive pressure lumen wall 206.
• the thickness of negative pressure lumen wall 203 may range from one and a half to three times as thick as that of positive pressure lumen wall 202.
• This thin wall construction permits the collapse of tubular member 202 including positive pressure lumen 205 and wall 206 about tubular member 201 as depicted in FIG. 3.
• a hemodialysis catheter typically having a maximum cross-sectional dimension of 18 French can be percutaneously inserted with stiffening cannula 109 over wire guide 110 into a blood vessel through a much smaller 12 French diameter peel-away introducer sheath 301.
• FIG. 4 Depicted in FIG. 4 is a cross-sectional view of proximal segment 103 along the line 4--4 of FIG. 1.
• the cross-sectional shape 401 of the proximal segment is formed to provide a tight fit between the main catheter body and the vascular access insertion site.
• the cross-sectional shape is elliptical to prevent the seepage of blood from the vascular access site along the outside surface of the proximal segment of the main catheter body.
• Respective negative and positive pressure lumens 204 and 205 extend entirely through proximal segment 103.
• a wire guide 110 is inserted through an introducer needle into the accessed vein.
• the introducer needle is removed, and a 12 French sheath mounted on a dilator is directly inserted over the guidewire into the vein.
• Stiffening cannula 109 is inserted through the negative pressure lumen of the arterial clamping limb 104, proximal segment 103, and out the distal tip end of distal segment 102.
• the catheter and stiffening cannula are inserted over wire guide 110 and through the peel-away sheath with the thin-walled tubular member 202 collapsed.
• the peel-away sheath is removed after the distal segment is inserted through the sheath into the vein.
• a short distal portion of the elliptically shaped proximal segment 103 is then inserted through the venous access site into the vein, thereby establishing a relatively tight and leak-proof seal.
• Grommet 116 is mounted onto the catheter by passing it over the distal tip, after the catheter has been pulled up through the subcutaneous tunnel and before the catheter is inserted through the sheath into the vein. Grommet 116 slides the distal segment and a length of proximal segment 103 and is placed strategically in the supraclavicular fossa and anchored to the subcutaneous tissue before the supraclavicular wound is closed. Final position of the grommet will vary in each patient according to how much length of the catheter is desired in the blood vessel.
• the afore-mentioned dual lumen extracorporeal treatment catheter is merely illustrative of the application of the principles of this invention and that numerous other arrangements may be devised by those skilled in the art without departing from the spirit and scope of the invention.
• a number of other grommets may be slid over or attached to the proximal segment of the catheter for anchoring the catheter to surrounding tissue.
• the catheter may also include any number of other connectors or clamping devices for use with the arterial and venous clamping limbs.
• the shape of the lumens may be varied to an elliptical or even crescent shape; however, the radii of lumen shapes need to be maximized to prevent or minimize turbulent blood flow and the possibility of clotting.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
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Abstract

Description

Claims (20)

Priority Applications (7)

Applications Claiming Priority (1)

Publications (1)

Family

ID=24043511

Family Applications (1)

Country Status (7)

Cited By (203)

Families Citing this family (28)

Citations (20)

Family Cites Families (4)

• 1990
  • 1990-04-20 US US07/513,491 patent/US5106368A/en not_active Expired - Lifetime
• 1991
  • 1991-04-08 JP JP10171091A patent/JP3208454B2/en not_active Expired - Fee Related
  • 1991-04-16 DE DE69130267T patent/DE69130267T2/en not_active Expired - Fee Related
  • 1991-04-16 ES ES91303368T patent/ES2121769T3/en not_active Expired - Lifetime
  • 1991-04-16 EP EP91303368A patent/EP0453234B1/en not_active Expired - Lifetime
  • 1991-04-17 CA CA002040708A patent/CA2040708C/en not_active Expired - Fee Related
  • 1991-04-19 AU AU75196/91A patent/AU640772B2/en not_active Ceased

Patent Citations (20)

Non-Patent Citations (6)